Opportunity Information: Apply for RFA FD 15 008
Apply for RFA FD 15 008
- The Food Drug Administration in the consumer protection food and nutrition health sector is offering a public funding opportunity titled "Pharmacometric Modeling and Simulation for Long Acting Injectable Products (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103 Food and Drug AdministrationResearch.
- This funding opportunity was created on Feb 17, 2015 and posted on Feb 17, 2015.
- Applicants must submit their applications by Apr 27, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $600,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $200,000.00 in funding.
- The number of recipients for this funding is limited to 3 candidate(s).
- Eligible applicants include: Public and State controlled institutions of higher education Special district governments Small businesses State governments County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Public housing authorities/Indian housing authorities Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) For profit organizations other than small businesses Native American tribal governments (Federally recognized) City or township governments.
- Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the HHS Grants Policy Statement, are allowed.
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Opportunity Summary:
Pharmacometric Modeling and Simulation for Long Acting Injectable Products (U01) (Funding Opportunity Number RFA-FD-15-008) was a U.S. Food and Drug Administration (FDA) discretionary research funding opportunity offered as a cooperative agreement. It focused on improving how long-acting injectable (LAI) drug products, especially generics, can be evaluated for bioequivalence and therapeutic equivalence using modern pharmacometric approaches. The overall goal was to generate modeling, simulation, and statistical evidence that can be translated into clearer scientific expectations and more consistent regulatory standards for demonstrating that a generic LAI performs the same as its reference product in patients.
The project was organized around two tightly related technical subtopics. Subtopic 1 emphasized physiologically based pharmacokinetic (PBPK) modeling, with the specific intent of linking a product's critical quality attributes (CQAs) to in vivo performance. In practical terms, this subtopic sought to use mechanistic PBPK models to connect what is measured and controlled during formulation and manufacturing (such as particle size distribution, drug release characteristics, viscosity, excipient effects, depot formation behavior, and other attributes that can influence absorption and disposition) to the resulting pharmacokinetic profile in the body. By building these connections, the work aimed to strengthen bioequivalence (BE) evaluation for LAIs, where traditional approaches can be difficult due to complex absorption phases, long half-lives, and sensitivity to formulation or process changes.
Subtopic 2 focused on population pharmacokinetic/pharmacodynamic (PK/PD) modeling and statistical analysis, aimed at tackling the high variability that often appears in LAI studies and makes BE testing challenging. The intent here was to identify strategies to reduce unexplained (residual) variability, determine which pharmacokinetic metrics are most appropriate for BE decisions in this product class, and enable BE assessment in parallel-group study designs with acceptable sample sizes. This matters because crossover designs can be impractical for many LAIs due to long washout periods, and parallel designs typically require larger enrollment, especially when variability is high. By improving model-based understanding and choosing better endpoints or metrics, the program aimed to make BE studies more feasible while still being scientifically rigorous.
From an administrative and funding standpoint, FDA expected to make about three awards, with an estimated total funding level of $600,000. The anticipated maximum (ceiling) per award was $200,000, and the opportunity did not require cost sharing or matching. As a cooperative agreement (U01), the mechanism implied active FDA involvement during the project period, typically meaning that awardees would collaborate with FDA scientific staff, align on technical milestones, and produce outputs that are directly useful for regulatory science and policy development.
Eligibility was broad and included many types of applicants such as public and private institutions of higher education, nonprofits (including both 501(c)(3) and non-501(c)(3) organizations), small businesses and other for-profit organizations, and various levels of government (state, county, city/township, special districts, independent school districts, and housing authorities). Importantly, non-U.S. entities were eligible: foreign institutions could apply, non-U.S. components of U.S. organizations were eligible, and foreign components were allowed as defined under HHS grants policy. The opportunity was posted on February 17, 2015, with an application closing date of April 27, 2015, and it was later archived on May 27, 2015. The associated CFDA listing was 93.103 under FDA Research.
The underlying takeaway of the opportunity is that FDA was investing in modeling and simulation tools that can make BE and therapeutic equivalence assessments for generic LAI products more scientifically grounded and more practical to execute. By tying CQAs to clinical performance through PBPK and by using population PK/PD and improved statistical methods to manage variability and select appropriate BE metrics, the funded work was intended to support clearer regulatory pathways and greater confidence that approved generic LAIs will match their reference products in real-world therapeutic outcomes. For access to the full announcement details, the opportunity referenced the NIH Guide posting for RFA-FD-15-008, and the grants management contact listed was Lisa Ko (lisa.ko@fda.hhs.gov).
Frequently Asked Questions (FAQs)
What is the title and funding opportunity number for this grant?
The opportunity is titled Pharmacometric Modeling and Simulation for Long Acting Injectable Products (U01) and the Funding Opportunity Number is RFA-FD-15-008.
Which federal agency offered this funding opportunity?
This was a discretionary research funding opportunity offered by the U.S. Food and Drug Administration (FDA).
What type of award mechanism was used?
The award mechanism was a cooperative agreement (U01), which typically indicates active FDA involvement during the project period.
What does “cooperative agreement (U01)” mean in practical terms for awardees?
As described, a U01 implies active FDA participation, meaning awardees would generally collaborate with FDA scientific staff, align on technical milestones, and generate outputs intended to be directly useful for regulatory science and policy development.
What was the overall goal of the program?
The goal was to generate modeling, simulation, and statistical evidence that could be translated into clearer scientific expectations and more consistent regulatory standards for demonstrating that a generic long-acting injectable (LAI) performs the same as its reference product in patients (bioequivalence and therapeutic equivalence).
What product area did this opportunity focus on?
It focused on long-acting injectable (LAI) drug products, with special emphasis on improving evaluation approaches for generic LAIs.
What regulatory science problem was FDA trying to address with this funding?
FDA aimed to improve how LAIs can be evaluated for bioequivalence (BE) and therapeutic equivalence, especially where traditional approaches are difficult due to complex absorption phases, long half-lives, and sensitivity to formulation or process changes.
How was the research scope organized?
The project scope was organized into two tightly related technical subtopics: (1) PBPK modeling to connect critical quality attributes to in vivo performance, and (2) population PK/PD modeling plus statistical analysis to address variability and BE study feasibility.
What was Subtopic 1 about?
Subtopic 1 emphasized physiologically based pharmacokinetic (PBPK) modeling, with the intent of linking a product’s critical quality attributes (CQAs) to in vivo performance.
What kinds of “critical quality attributes” (CQAs) were mentioned?
The description cited attributes measured or controlled during formulation/manufacturing that can influence absorption and disposition, including particle size distribution, drug release characteristics, viscosity, excipient effects, depot formation behavior, and other attributes affecting PK performance.
What was the practical intent of using PBPK models in Subtopic 1?
The intent was to use mechanistic PBPK models to connect formulation and manufacturing attributes (CQAs) to the resulting pharmacokinetic profile in the body, thereby strengthening BE evaluation for LAIs.
Why did FDA consider traditional BE approaches difficult for LAIs?
The description notes challenges such as complex absorption phases, long half-lives, and sensitivity of LAI performance to formulation or manufacturing/process changes.
What was Subtopic 2 about?
Subtopic 2 focused on population pharmacokinetic/pharmacodynamic (PK/PD) modeling and statistical analysis to address high variability in LAI studies and to improve the feasibility and rigor of BE testing.
What specific challenges was Subtopic 2 intended to tackle?
Subtopic 2 aimed to: (1) identify strategies to reduce unexplained (residual) variability, (2) determine which pharmacokinetic metrics are most appropriate for BE decisions in LAIs, and (3) enable BE assessment in parallel-group study designs with acceptable sample sizes.
Why were parallel-group designs emphasized for LAI BE assessment?
Because crossover designs can be impractical for many LAIs due to long washout periods. Parallel designs may be more practical but can require larger enrollment, especially when variability is high.
How was the work expected to improve BE study feasibility without sacrificing rigor?
By improving model-based understanding of LAI behavior and supporting selection of better endpoints or metrics, the program aimed to make BE studies more feasible while remaining scientifically rigorous.
How many awards did FDA anticipate making?
FDA expected to make about three awards.
What was the estimated total funding level for the opportunity?
The estimated total funding level was $600,000.
What was the maximum funding amount per award?
The anticipated maximum (ceiling) per award was $200,000.
Was cost sharing or matching required?
No. The opportunity did not require cost sharing or matching.
Who was eligible to apply?
Eligibility was broad and included: public and private institutions of higher education, nonprofits (both 501(c)(3) and non-501(c)(3)), small businesses and other for-profit organizations, and multiple levels of government (state, county, city/township, special districts, independent school districts, and housing authorities).
Were foreign (non-U.S.) organizations eligible?
Yes. The opportunity stated that foreign institutions could apply, non-U.S. components of U.S. organizations were eligible, and foreign components were allowed as defined under HHS grants policy.
When was the opportunity posted and when did it close?
It was posted on February 17, 2015 and the application closing date was April 27, 2015.
When was the opportunity archived?
The opportunity was later archived on May 27, 2015.
What CFDA listing was associated with this opportunity?
The associated CFDA listing was 93.103 under FDA Research.
Where was the full announcement referenced?
The opportunity referenced the NIH Guide posting for RFA-FD-15-008 for full announcement details.
Who was listed as the grants management contact?
The grants management contact listed was Lisa Ko (lisa.ko@fda.hhs.gov).
What was the main expected impact of the funded research?
The underlying takeaway was that FDA was investing in modeling and simulation tools to make BE and therapeutic equivalence assessments for generic LAIs more scientifically grounded and more practical, supporting clearer regulatory pathways and greater confidence that approved generic LAIs match reference products in real-world therapeutic outcomes.
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